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      Effect of ospemifene on moderate or severe symptoms of vulvar and vaginal atrophy


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          Objectives To determine whether assessment of all moderate-to-severe symptoms at baseline gives a more accurate evaluation of the treatment effect of ospemifene in vulvovaginal atrophy (VVA) than the most bothersome symptom (MBS) approach.

          Methods Data were pooled from two pivotal phase-III clinical trials evaluating the efficacy and safety of oral ospemifene 60 mg/day for the treatment of symptoms of VVA ( n = 1463 subjects). Symptoms of vaginal dryness, dyspareunia, and vaginal and/or vulvar irritation/itching reported as moderate or severe at baseline were evaluated. Clinically relevant differences between ospemifene and placebo were analyzed using a four-point severity scoring system and presented as improvement, substantial improvement, or relief.

          Results Subjects in these studies reported statistically significant improvement, substantial improvement, and relief for vaginal dryness ( p < 0.00001), dyspareunia ( p < 0.001) and statistically significant improvement and relief for vaginal and/or vulvar irritation/itching ( p < 0.01) from baseline to week 12 with ospemifene compared with placebo. A similar trend was observed for women who reported substantial improvement of vaginal and/or vulvar irritation/itching.

          Conclusions For drug registration purposes, the use of the MBS model is appealing because of its simplicity and ease of scientific validation. However, the MBS model may underestimate the total magnitude of the clinical benefit of ospemifene treatment for symptomatic women suffering from VVA.

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          Most cited references15

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          A prospective population-based study of menopausal symptoms.

          To identify symptoms that change in prevalence and severity during midlife and evaluate their relationships to menopausal status, hormonal levels, and other factors. In a longitudinal, population-based study of 438 Australian-born women observed for 7 years with an 89% retention rate, 172 advanced from premenopause to perimenopause or postmenopause. Annual measures included a 33-item symptom check list; psychosocial, lifestyle, and health-related factors; menstrual status; hormone usage; and blood levels of follicle-stimulating hormone and estradiol (E2). Increasing from early to late perimenopause were the number of women who reported five or more symptoms (+14%), hot flushes (+27%), night sweats (+17%) and vaginal dryness (+17%) (all P <.05). Breast soreness-tenderness decreased with the menopausal transition (-21%). Trouble sleeping increased by +6%. The major change in prevalence was from early to late perimenopause, except for insomnia, which showed a gradual increase. Those variables most related to onset of hot flushes were number of symptoms at early perimenopause (P <.05), having an unskilled or no occupation (P <.05), more than 10 pack-years of smoking (P <.01), and decreased E2 (P <.01). The onset of night sweats increased with the change in E2 (P <.05). The onset of vaginal dryness decreased with more years of education (P <.05). Trouble sleeping was predicted by prior lower well-being (P <.01), belief at baseline that women with many interests hardly notice menopause (P <.01), and hot flushes (P <.01). Although middle-aged women are highly symptomatic, the symptoms that appear to be specifically related to hormonal changes of menopausal transition are vasomotor symptoms, vaginal dryness, and breast tenderness. Insomnia reflected bothersome hot flushes and psychosocial factors.
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            Vulvovaginal atrophy.

            Vulvovaginal atrophy (VVA) is a common and underreported condition associated with decreased estrogenization of the vaginal tissue. Symptoms include dryness, irritation, soreness, and dyspareunia with urinary frequency, urgency, and urge incontinence. It can occur at any time in a woman's life cycle, although more commonly in the postmenopausal phase, during which the prevalence is close to 50%. Clinical findings include the presence of pale and dry vulvovaginal mucosa with petechiae. Vaginal rugae disappear, and the cervix may become flush with the vaginal wall. A vaginal pH of 4.6 or more supports the diagnosis of VVA. Even while taking systemic estrogen, 10% to 20% of women may still have residual VVA symptoms. Breast cancer treatment increases the prevalence of VVA because the surgical, endocrine, and chemotherapeutic agents used in its treatment can cause or exacerbate VVA. Local estrogen treatment for this group of women remains controversial.
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              Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey.

              Vulvar and vaginal atrophy (VVA) is a chronic medical condition experienced by many postmenopausal women. Symptoms include dyspareunia (pain with intercourse), vaginal dryness, and irritation and may affect sexual activities, relationships, and activities of daily life.

                Author and article information

                Taylor & Francis
                2 January 2016
                19 November 2015
                : 19
                : 1
                : 60-65
                [ a ]BrInPhar Ltd Iver Heath, UK
                [ b ]Research Center for Reproductive Medicine, Gynecological Endocrinology and Menopause, IRCCS S Matteo Foundation, University of Pavia Pavia, Italy
                [ c ]Clinic Institute of Gynecology, Obstetrics and Neonatology, Hospital Clinic and Faculty of Medicine, University of Barcelona - Institut d'Investigacions Biomèdiques August Pi i Sunyer , Barcelona, Spain
                [ d ]Mediclinic Panorama and Department of Obstetrics and Gynecology, Faculty of Health Sciences, Stellenbosch University , Parow, South Africa
                [ e ]Department of Obstetrics and Gynecology, George Washington University, Women’s Health & Research Consultants® , Washington DC, USA
                Author notes
                CONTACT Dr N. Bruyniks nico.bruyniks@ 123456gmail.com BrInPhar Ltd , Crowther Lodge, Cherrytree Lane, Iver Heath SL0 0EE, UK
                © 2015 N. Bruyniks

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License ( http://creativecommons.org/Licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.

                : 30 July 2015
                : 16 October 2015
                : 25 October 2015
                Page count
                Pages: 6
                Original Article

                Obstetrics & Gynecology
                vulvar and vaginal atrophy,ospemifene,randomized clinical trials
                Obstetrics & Gynecology
                vulvar and vaginal atrophy, ospemifene, randomized clinical trials


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